Demand for laboratory tests; including drug and alcohol tests, blood sugar level tests, and others, has steadily increased as these tests have gained wide acceptance in the medical field, law enforcement, and employment screenings. Until recently, the entire procedure for collecting, preparing and testing samples was limited to the speed and accuracy of trained personnel. However, within the last decade, laboratories and other testing facilities have trended towards at least a partially automated process, and have incorporated the use of machinery to assist in the preparation and testing of samples.
Prior to the introduction of automated machines into the field, a user would deposit a sample of urine, blood or other bodily fluid into a sample container. The sample container would be sealed by a medical professional, usually with a tamper-evident tape, and transferred to a laboratory for measurement and analysis. Once the sample container is received in the laboratory, caution is taken to ensure that the sample container remains sealed, such that unwanted contaminants are prevented from entering the sample container. A laboratory technician would then open each sample container, individually, and introduce an aliquot of the sample to a testing vial for processing in an analytical testing machine.
Because this system was subject to human errors, testing results were often subject to inaccuracies resulting from mislabeling, cross-contamination, and others. Human technicians are subject to fatigue, attention-span limitations, physical limitations, and other limitations which have been shown to reflect on an increased error percentage, especially as duration of a shift is increased. As requirements for testing increase, technicians were required to work longer shifts, and in turn, an increase in errors became prevalent in the industry.
Recently, there has been a trend towards automated machinery for processing and testing samples in the laboratory. U.S. Pat. No. 6,531,096, filed Oct. 6, 1998, and entitled “METHOD AND APPARATUS FOR AUTOMATICALLY OPENING AND CLOSING VIAL LIDS”, herein referred to as the '096 patent, discloses one automated solution for opening tamper-sealed vials and sampling the contents thereof, the entire contents of which are hereby incorporated by reference.
Although the '096 patent provided a solution for minimizing human errors and increasing throughput of samples by automating portions of the testing process, several problems remain yet to be solved.
In the laboratory sampling and testing industry, there is a continued need for reducing sample-to-sample cross-contamination, and environment-to-sample cross contamination. The embodiments described in the '096 patent provide a sample station immediately adjacent to the testing vial station, therefore failing to sufficiently isolate the opening of sample containers from testing vials. This system has a significant potential for cross-contamination of samples.
Another limitation with the embodiments disclosed in the '096 patent relates to machine malfunctions, or jams. Under the embodiments disclosed in the '096 patent, a machine jam requires an operator to remove each of the vials from the rack, fix the machine malfunction, and then replace the vials, therefore causing a concern for cross contamination. It would be beneficial to provide a machine adapted to process each sample independently, such that the need to remove sample containers and testing vials, and corresponding risks for cross contamination are eliminated.
The embodiments of the prior art, including the '096 patent, require the use of a scoring member to score the tamper-evident tape maintaining the sample containers in a closed position. The scoring allows the machine to open the sample containers for processing. Without scoring the tamper-evident tape, machines of the prior art are unable to effectively open the sample containers. It would be beneficial in the art if the current requirement for scoring tamper-evident tape was eliminated, such that the time require to process samples can be decreased, and high-throughput of samples can be achieved efficiently.
Input and Output buffers, i.e. conveyors for positioning sample racks, as disclosed in the '096 patent, are inherently troublesome and contribute to additional risks for machine failures, or jams. For example, in the laboratory environment a technician must take caution for placing objects near moving parts. Technicians have been known to set objects on machines, such as pens and pencils, papers, clip boards, sample containers, and other objects. The conveyors, which move at time-delineated intervals, may periodically appear to be stationary, and a technician may set an object on the machine conveyor. Alternatively, a foreign object may land on the conveyor or after a period of time a spill or other object may collect on the conveyor, such that the conveyor eventually malfunctions, and causes the machine to jam. Fewer moving parts exposed to the operator would minimize risks associated with machine malfunctions, and ultimately cross-contamination. Additionally, conveyor belts tend to stretch over time and eventually lead to mechanical malfunctions. Therefore, it would be beneficial to provide a machine that uses fewer exposed moving parts, such as conveyors, such that risks for mechanical errors and contamination are sufficiently minimized.
Another limitation to automated sampling machines as currently known and described in the prior art, relates to the size of the machines. For example, as described in the '096 patent, the prior art embodiments require a first station to transfer aliquots from each sample container to a vial, and multiple other stations. These machines are required to move the sample to various stations for performing several functions. The additional stations require a sizable area for operation. As is understood by one having skill in the art, laboratory space is expensive and often limited. Large machines are therefore discouraged. Additionally, the excess power used by larger machines, especially those machines having multiple stations for activity, is of concern. It would be an improvement in the art if a machine were provided which could process samples under the requirement for smaller floor, or bench top space. It would be an additional benefit if the machine were capable of high-throughput sampling while consuming less power, and further beneficial if a robot were provided for transferring samples such that the sample containers remain in a stationary position.
Further limitations in the art include machines having multiple barcode readers fixedly disposed throughout multiple stations of the machine. Here, a robot would pass by a barcode reader at a fixed location, and a read would be performed such that information is recorded. One problem with these machines includes the cost associated with the several barcode readers, the maintenance involved with the system of barcode readers, and the added space and power requirements of the machine.
The inventors of the present invention recognized that if would be of further benefit to provide samples that are tracked at each stage of the collection, preparation, and testing process, such that results can be quality controlled and assured, this is referred to in the art as Chain of Custody (COC). Currently available machines do not maintain a proper chain of custody. It would be beneficial to the art if a machine were provided being capable of separately processing each sample, such that a chain of custody can be accurately recorded.
In sum of the foregoing problems and limitations of prior art equipment, it would be beneficial to provide a machine for processing laboratory samples, the machine being capable of automated processing such that high-throughput of samples can be achieved. It would be further beneficial to provide a machine capable of opening sample containers individually, and in a region where no other sample containers or testing vials can be exposed to spillage, such that risks for cross-contamination are eliminated. It would be beneficial to provide a machine which processes each sample individually, such that upon a machine malfunction, the integrity of a single sample can be inspected in isolation from other samples. It would be beneficial to provide a machine capable of opening sample containers without the need for a scoring object, such that sample processing time is decreased and machine space and power requirements are conserved. It would further benefit the art if a machine were provided having fewer exposed moving parts, such that machine malfunctions and resulting contaminations can be minimized. It would be beneficial in the art to provide a machine requiring smaller floor or bench-top space. It would be beneficial to provide a machine for processing samples while consuming less power. Finally, it would be beneficial to provide a machine which processed samples individually, and recorded data associated with each step of the process, such that Chain of Custody can be recorded and subsequently verified in compliance with a quality protocol.